1. Field of the Invention
The present invention relates to a method and apparatus for attaching a sterile sleeve to a connector, such as a distal fitting for the sterile sleeve, and the assembly formed thereby. More specifically, the method and apparatus enable a sterile sleeve to be attached to a connector in such a manner that a loose end of the sleeve is tucked within the body of the sleeve and over a portion of the body of the connector, as will be described in greater detail hereinafter.
2. Description of the Prior Art
Heretofore various methods and apparatus have been proposed for forming a joint or sealed coupling between a sterile sleeve and a connector therefor. All such methods and apparatus form the joint or coupling by placing an end section of a sterile sleeve over a connector body and then feeding an O-ring over the end of the, sterile sleeve and/or the connector body for securing the sterile sleeve to the connector body when the O-ring placed over the sleeve and connector is received within an annular groove provided on the connector body.
An example of such sterile sleeve/connector assembly is disclosed in the Hampson U.S. Pat. No. 4,327,735 the disclosure of which is incorporated herein by reference. As disclosed in this patent, a sleeve/introducer assembly is fitted over a medical catheter for the purpose of protecting the catheter within the sleeve from contaminants thereby to maintain the catheter in a sterile condition.
Applicant's assignee, Cordis Corporation of Miami Lakes, Florida, sells such sleeve/introducer assemblies under the name or mark "Steri-Sleeve" which is a contraction of the term "Sterile Sleeve" used herein.
Such a "Steri-Sleeve" is disclosed on page 102 of the January 1988 Cordis Corporation Catalog, the disclosure of which is incorporated herein by reference.
Such joints or couplings formed by prior art methods and apparatus have left a straggling, loose end of the sterile sleeve extending from the O-ring over the connector body to which the sterile sleeve is joined Such a straggling loose end makes separation of the joint simple All a user need do is gently pull on the sleeve, against. the O-ring, and remove the sleeve from entrapment beneath the O-ring to cause a separation of the sleeve from the connector.
By utilization of the apparatus and method of the present invention in forming the joint in a sterile sleeve/connector assembly of the present invention, the O-ring is received within or encased within an inwardly turned or inverted looped end portion of the sterile sleeve, with the previously straggling, loose end portion of the sterile sleeve now extending inwardly into the lumen of the sterile sleeve with the O-ring positioned to entrap the inwardly extending end portion of the sleeve within an O-ring receiving annular groove provided on a connector, with the remainder of the sterile sleeve looping outwardly and back over the entrapped end portion of the sterile sleeve and extending over the connector. Such joint or coupling formed by the method and apparatus of the present invention provides a joint which is much more difficult to separate and provides a neat termination of the sleeve about the O-ring and over the connector in the manner described so that there is no loose straggling end, making the external surface of the joint more regular.
As will be described in greater detail hereinafter, it is believed that the joint in a sterile sleeve/connector assembly of the present invention can only be accomplished by use of the particular method and apparatus disclosed herein.